[Federal Register Volume 71, Number 27 (Thursday, February 9, 2006)]
[Proposed Rules]
[Pages 6733-6743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1797]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 707 and 799
[EPA-HQ-OPPT-2005-0058; FRL-7752-2]
RIN 2070-AJ01
Export Notification; Proposed Change to Reporting Requirements
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing amendments to the Toxic Substances Control
Act (TSCA) section 12(b) export notification regulations at subpart D
of 40 CFR part 707. One amendment would change the current annual
notification requirement to a one-time requirement for exporters of
chemical substances or mixtures (hereinafter referred to as
``chemicals'') for which certain actions have been taken under TSCA.
Relatedly, for the same TSCA actions, EPA is proposing to change the
current requirement that the Agency notify foreign governments annually
after the Agency's receipt of export notifications from exporters to a
requirement that the Agency notify foreign governments once after it
[[Page 6734]]
receives the first export notification from an exporter. EPA is also
proposing de minimis concentration levels below which notification
would not be required for the export of any chemical for which export
notification under TSCA section 12(b) is otherwise required, proposing
other minor amendments (to update the EPA addresses to which export
notifications must be sent, to indicate that a single export
notification may refer to more than one section of TSCA where the
exported chemical is the subject of multiple TSCA actions, and to
correct an error), and clarifying exporters' and EPA's obligations
where an export notification-triggering action is taken with respect to
a chemical previously or currently subject to export notification due
to the existence of a previous triggering action.
DATES: Comments must be received on or before April 10, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2005-0058, by one of the following methods:
http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
Agency Website: EDOCKET, EPA's electronic public docket
and comment system, was replaced on November 25, 2005, by an enhanced
Federal-wide electronic docket management and comment system located at
http://www.regulations.gov. Follow the on-line instructions.
E-mail: [email protected].
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID number EPA-HQ-OPPT-2005-0058. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2005-0058. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or e-mail.
The www.regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through www.regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm/.
Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy
form. Publicly available docket materials are available either
electronically in www.regulations.gov or in hard copy at the OPPT
Docket (EPA/DC), EPA West, Rm. B102, 1301 Constitution Ave., NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is (202) 566-1744, and the telephone
number for the OPPT Docket is (202) 566-0280.
FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: [email protected].
For technical information contact: Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-9232; e-mail
address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you export or
intend to export any chemical substance or mixture for which any of the
following actions have been taken under TSCA with respect to that
chemical substance or mixture: Data are required under TSCA section 4
or 5(b), an order has been issued under TSCA section 5, a rule has been
proposed or promulgated under TSCA section 5 or 6, or an action is
pending, or relief has been granted under TSCA section 5 or 7.
Potentially affected entities may include, but are not limited to:
Exporters of chemical substances or mixtures (NAICS codes
325 and 324110; e.g., chemical manufacturing and processing and
petroleum refineries).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions at 40 CFR 707.60 for
TSCA section 12(b)-related obligations. If you have any questions
regarding the applicability of this action to a particular entity,
consult the technical person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using the electronic docket, you may access this
Federal Register document electronically through the EPA Internet under
the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A
frequently updated electronic version of both 40 CFR parts 707 and 799
are available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
C. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
http://
[[Page 6735]]
www.regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the rulemaking by docket ID number and other
identifying information (subject heading, Federal Register date and
page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
EPA is proposing amendments to TSCA section 12(b) export
notification regulations at subpart D of 40 CFR part 707. The first
amendment would change the current annual notification requirement for
exporters of chemicals for which certain actions have been taken under
TSCA. Currently, the TSCA section 12(b) regulations require exporters
of chemicals to notify EPA of the first export or intended export to a
particular country in a calendar year when data are required under TSCA
section 5(b), an order has been issued under TSCA section 5, a rule has
been proposed or promulgated under TSCA section 5 or 6, or an action is
pending, or relief has been granted under TSCA section 5 or 7. For
chemicals subject to a final TSCA section 4 action, exporters are
currently required to submit an export notification only for the first
export or intended export to a particular country. This proposed rule
would change the current annual export notification requirement to a
one-time requirement for each of the following TSCA section 12(b)-
triggering actions per each destination country for each exporter of a
chemical: An order issued, an action pending, or an action granting
relief under TSCA section 5(e), a proposed or promulgated rule under
TSCA section 5(a)(2), or an action requiring the submission of data
under TSCA section 5(b). For exports of chemicals that are the subjects
of TSCA section 12(b)-triggering actions under TSCA section 5(f), 6, or
7, however, each exporter would continue to be required to submit
annual export notifications to EPA.
Relatedly, EPA is proposing a change in the frequency for which the
Agency must notify foreign governments after the Agency's receipt of
export notifications from exporters. Consistent with the current
requirement that EPA notify foreign governments one time regarding the
export of chemicals subject to final TSCA section 4 actions, EPA is
proposing that the Agency provide a one-time (rather than the current
annual) notice to each foreign government to which exported chemicals
that are the subjects of any of the following actions are sent: An
order issued, an action pending, or an action granting relief under
TSCA section 5(e), a rule proposed or promulgated under TSCA section
5(a)(2), or an action requiring the submission of data under TSCA
section 5(b). EPA would continue to notify each foreign government on
an annual basis regarding the export of chemicals that are the subject
of TSCA section 5(f), 6, or 7 actions.
EPA is also proposing de minimis concentration levels below which
notification would not be required for the export of any chemical for
which export notification under TSCA section 12(b) is otherwise
required. Specifically, EPA is proposing that export notification would
not be required for such chemicals if the chemical is being exported at
a concentration of less than 1% (by weight or volume), unless that
chemical is:
1. Listed as a ``known to be human carcinogen'' or ``reasonably
anticipated to be human carcinogen'' in the Report on Carcinogens
issued by the U.S. Department of Health and Human Services National
Toxicology Program (NTP) (Ref. 1),
2. Classified as a Group 1, Group 2A, or Group 2B carcinogen by the
World Health Organization International Agency for Research on Cancer
(IARC) in the list of IARC Monographs on the Evaluation of Carcinogenic
Risks to Humans and their Supplements (Ref. 2), or
3. Characterized as a carcinogen or potential carcinogen in the
Occupational Safety and Health Administration's (OSHA's) regulations
related to toxic and hazardous substances (29 CFR part 1910, subpart
Z).
For paragraphs 1-3 of this unit, a de minimis concentration level of
less than 0.1% (by weight or volume) would apply. For exports of
polychlorinated biphenyls (PCBs), notification would not be required if
such chemicals are being exported at a concentration of less than or
equal to 50 parts per million (ppm) (by weight or volume).
EPA believes this proposed rule is needed to further focus
importing governments' resources and attention on chemicals for which
EPA has proposed to make or has made a finding under TSCA that a
chemical substance or mixture ``presents or will present'' an
unreasonable risk, and to reduce overall burden on exporters and the
Agency. EPA requests comments on these proposed amendments, and is
particularly interested in receiving comments discussing whether the
proposed changes would continue to provide adequate notice and
information to foreign governments about chemicals imported from the
United States. EPA is also interested in receiving specific, well
supported, information regarding how the proposed changes would affect
exporters.
In this Federal Register document, EPA is also updating the
instructions for the submission of export notifications to the Agency
(40 CFR 707.65(c)), clarifying exporters' and EPA's obligations when
subsequent TSCA section 12(b)-triggering actions are taken with respect
to a chemical previously or currently subject to export notification
due to a separate triggering action, indicating in 40 CFR 707.67 that a
single export notification may refer to more than one section of TSCA
where the exported chemical is the subject of multiple TSCA actions,
and correcting 40 CFR 799.19 to make it clear that final multi-chemical
TSCA section 4 rules also trigger export notification (see Unit IV.).
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B. What is the Agency's Authority for Taking this Action?
EPA is proposing these amendments pursuant to TSCA section 12(b),
15 U.S.C. 2611(b). Section 12(b) of TSCA requires that any person who
exports or intends to export to a foreign country a chemical for which
the submission of data is required under TSCA section 4 or 5(b), an
order has been issued under TSCA section 5, a rule has been proposed or
promulgated under TSCA section 5 or 6, or with respect to which an
action is pending or relief has been granted under TSCA section 5 or 7
must notify the Administrator of EPA of such exportation or intent to
export. Upon receipt of such notification, EPA must furnish the
government of the importing country with:
1. Notice of the availability of data received pursuant to an
action under TSCA section 4 or 5(b) or
2. Notice of such rule, order, action, or relief under TSCA section
5, 6, or 7.
C. History
In the Federal Register of December 16, 1980, EPA promulgated rules
at 40 CFR part 707, subpart D, implementing TSCA section 12(b) (Ref.
3). Under these rules, exporters were required to submit a written
notification to EPA for the first export or intended export to a
particular country in a calendar year for any chemical that was the
subject of a TSCA section 12(b)-triggering action. Upon receipt of such
notification from an exporter, the implementing rules required (and
still require) that EPA provide the importing country with, among other
things, a summary of the action taken or an indication of the
availability of data received pursuant to action under TSCA section 4
or 5(b) (see 40 CFR 707.70(b)).
To facilitate foreign governments' consideration of export notices
for chemicals exported from the United States and to reduce the burden
on EPA and exporters, EPA promulgated a rule in the Federal Register of
July 27, 1993, that amended the regulations in 40 CFR part 707, subpart
D (Ref. 4). The amendment limited the notification requirement for each
exporter of chemicals subject to a final TSCA section 4 action to a
one-time notification to EPA for the export of each such chemical to
each particular country, instead of requiring annual notification to
EPA for shipments of the chemical to that country. The amended rule
also limited EPA's notice to foreign governments to one time for the
export of each chemical subject to a final TSCA section 4 action. The
1993 amendment did not change the export notification requirements for
chemicals that are the subject of an action under TSCA section 5, 6, or
7; that is, exporters are currently required to provide annual
notification of the export of each chemical that is the subject of an
action under TSCA section 5, 6, or 7. The 1993 amendment also did not
change the frequency of EPA's notice to foreign governments for
chemicals subject to TSCA section 5, 6, or 7; EPA notice is provided
upon receipt of the first annual export notification for each such
chemical to each country.
In support of the 1993 amendment, EPA indicated that an increase in
the number of TSCA section 12(b) export notifications during the 1980s
made import monitoring more difficult for many foreign countries, and
imposed an increasing burden upon foreign governments, industry, and
EPA resources. EPA had determined that much of the increase in
notifications was associated with the export or intended export of
chemicals subject to final TSCA section 4 actions. At the time, EPA
believed that the increasing volume of notices made it difficult for
foreign countries which receive a large number of notices to generally
distinguish between those chemicals for which, for example, EPA had
taken an action to restrict use and those chemicals for which EPA has
required the generation of data but has not taken an action to restrict
use. By decreasing the volume of notices importing countries receive on
chemicals subject to final TSCA section 4 actions, EPA believed that
the 1993 amendment could increase the relative effectiveness of notices
by allowing foreign governments to better focus their efforts on
notices for chemicals that are the subject of actions under TSCA
section 5, 6, or 7.
To further reduce the information collection burden for TSCA
section 12(b) export notification, EPA developed and periodically
updates a website that provides a list of chemicals subject to TSCA
section 12(b) export notification requirements (see ``Current List of
Chemical Substances Subject to TSCA Section 12(b) Export Notification
Requirements'' at http://www.epa.gov/opptintr/chemtest/main12b.htm). In
addition, exporters' obligation to submit a one-time export
notification to EPA for the export of a chemical subject to a final
TSCA section 4 action terminates once the reimbursement period for that
particular action expires. OPPT has made available a comprehensive
listing of these ``sunset'' dates for all such chemicals (see ``Sunset
Date/Status of TSCA Section 4 Testing, Reimbursement, and Reporting
Requirements and TSCA Section 4-Triggered TSCA Section 12(b) Export
Notification Requirements'' at http://www.epa.gov/opptintr/chemtest/sunset.htm). The regulated community has indicated that these lists
serve as useful tools to assist exporters in complying with TSCA and
EPA believes that they have resulted in an overall reduction of the
information collection burden associated with TSCA section 12(b) export
notification requirements.
D. Rotterdam Convention
EPA notes as further background the Rotterdam Convention on the
Prior Informed Consent Procedure for Certain Hazardous Chemicals and
Pesticides in International Trade (Rotterdam Convention) (Ref. 5), a
multi-lateral environmental agreement that the United States signed in
September of 1998 but has not yet ratified (and thus is not a Party
to). This Rotterdam Convention, which went into force in February of
2004, includes the following major obligations:
1. Notification of control action and imposition of export
notification requirement on exporters. The Rotterdam Convention
requires exporting parties to: Determine whether a pesticide or
industrial chemical is ``banned'' or ``severely restricted'' (BSR);
notify the Secretariat of that determination; and notify importing
parties of the export of those chemicals from their country prior to
their export after making the BSR determination and thereafter for the
first export of every calendar year.
2. Impose export restrictions consistent with importing parties
response. Once a BSR chemical (and its use category, i.e., use as a
pesticide or industrial chemical) is, by consensus of the Parties,
added to Annex III of the Rotterdam Convention, the Rotterdam
Convention requires importing parties to identify any conditions/
restrictions on the import of these substances and exporting parties to
make sure exports occur consistent with conditions/restrictions
identified by importing countries. Annex III of the Rotterdam
Convention contains a list of chemicals that are subject to the Prior
Informed Consent Procedures described by the Rotterdam Convention (Ref.
5).
3. Label exported products. For countries' domestic BSR chemicals
and the Rotterdam Convention's Annex III chemicals, the Rotterdam
Convention requires labeling to ``ensure adequate availability of
information with regard to risks and/or hazards to human health or the
environment.'' For the Rotterdam Convention's Annex III chemicals,
labels must also include a Harmonized
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System Code if available (Ref. 6). For an exporting country's BSR
chemicals and the Rotterdam Convention's Annex III chemicals that are
to be used in an occupational setting, each exporting Party must send
the most up-to-date safety data sheet for the chemical to each
importer.
EPA believes the export notification mechanism in the Rotterdam
Convention broadly reflects importing governments' interests and that
this proposal to amend the TSCA section 12(b) export notification rule
is not inconsistent with the export notification provisions of the
Rotterdam Convention.
EPA wishes to note that the Administration is committed to the
United States becoming a Party to the Rotterdam Convention, as well as
two other chemicals-related multi-lateral environmental agreements: the
Stockholm Convention on Persistent Organic Pollutants (POPs) (Stockholm
Convention) (Ref. 7) and the POPs Protocol to the United Nations
Economic Commission for Europe Convention on Long Range Transboundary
Air Pollution (LRTAP) (Ref. 8). The Administration has been and intends
to continue working with Congress to facilitate the development of
legislation that would provide the authority needed for the United
States to fully implement and become a Party to those agreements. If
and when such legislation is enacted, and depending on the nature of
the legislation, it may be appropriate or necessary to further amend
the TSCA section 12(b) regulations.
III. Rationale for This Proposed Rule
EPA believes this proposed rule is a reasonable supplement to the
1993 amendments to EPA's export notification regulations because it
would further reduce overall burden on exporters and the Agency and
would further focus importing governments' resources and attention on
chemicals for which EPA has proposed to make or has made a definitive
finding that a chemical ``presents or will present'' an unreasonable
risk to human health or the environment.
In the 1993 amendments, it was EPA's view that TSCA section 5(a)(2)
and 5(e) actions, which are based on exposure or risk concerns for
identified use scenarios, ``restrict'' in a limited sense, regulated
uses. The 1993 amendments further stated that the Agency has authority
to take follow-up action under TSCA section 5(a)(2) via TSCA section
5(e) and because there is no similar provision under TSCA section 4
(with the exception of a separate proceeding under TSCA section 6 or
7), there was a reasonable basis for treating the export notification
requirement for chemicals regulated under TSCA sections 4 and 5
differently (Ref. 4, p. 40240). This proposed rule, however, would
treat actions under TSCA sections 5(a)(2) and 5(e) similarly to final
actions under TSCA section 4 for purposes of export notification, such
that a one-time notice would be required. Although TSCA sections
5(a)(2) and 5(e) restrict use in some sense, the statutory finding for
such actions is based on consideration of ``factors'' relating to a
``significant new use'' determination under TSCA section 5(a)(2) or,
for TSCA section 5(e), the same ``may present an reasonable risk'' or
``substantial production/significant/substantial exposure'' findings
required under TSCA section 4 rulemakings. EPA believes foreign
governments will want to focus greater attention on chemicals for which
the Agency has made a finding that a chemical ``presents or will
present'' an unreasonable risk to human health or the environment (TSCA
sections 5(f)(1), 6(a), and 7). This finding represents a definitive
determination and thus is different from a finding that a chemical
``may present'' an unreasonable risk (TSCA sections 4(a)(1)(A)(i) and
5(e)(1)(A)(ii)(I)), substantial production and substantial or
significant exposure/release findings (``exposure-based'' findings;
TSCA sections 4(a)(1)(B)(i), 5(b)(4)(A)(i), and 5(e)(1)(A)(ii)(II)), or
factors determining a significant new use (TSCA section 5(a)(2)).
Because ``presents or will present'' an unreasonable risk to human
health or the environment is a definitive risk determination, EPA
believes that it is reasonable to require more frequent notification
for those chemicals that are the subject of each export notification-
triggering action under TSCA sections 5(f), 6, and 7. Therefore, EPA
would continue to require annual export notification by exporters of
chemicals that are the subject of each action under TSCA section 5(f),
6, or 7, and EPA is similarly amending the regulatory provision
regarding EPA's notice to foreign governments to limit annual notices
to chemicals that are the subject of each TSCA section 5(f), 6, or 7
action.
EPA is also proposing de minimis concentration levels below which
notification would not be required for the export of any chemical that
is the subject of an action under TSCA section 4, 5, 6, or 7. In 1993,
EPA considered but did not adopt a de minimis concentration exemption
from its TSCA section 12(b) regulations, although the Agency expected
to re-examine that option if further experience indicated that such an
exemption would be warranted. Accordingly, this proposed rule provides
background on the use of de minimis concentration levels under an
international chemical classification and labeling scheme as a basis
for incorporation of a de minimis concentration level under TSCA
section 12(b).
The 1992 United Nations Conference on Environment and Development
(Ref. 9), provided the international mandate for development of the
Globally Harmonized System of Classification and Labelling of Chemicals
(GHS) (Ref. 10). The GHS was adopted by the United Nations Economic and
Social Council in July 2003 and is an internationally agreed upon tool
for chemical hazard communication that incorporates a harmonized
approach to hazard classification and provisions for standardized
labels and safety data sheets. The GHS labeling is intended to provide
a foundation for national programs to promote safer use, transport and
disposal of chemicals, and to facilitate international trade in
chemicals whose hazards have been properly assessed and identified
based on internationally agreed upon criteria. As with TSCA section
12(b), one of the primary purposes of the GHS labeling scheme is to
communicate information on chemicals to foreign governments.
Accordingly, EPA believes it is appropriate to look to GHS for guidance
on establishing a de minimis concentration exemption under TSCA section
12(b).
Classification of chemical mixtures under the GHS for several
health and environmental hazard classes is triggered when generic cut-
off values or concentration limits are exceeded, for example, >=1.0%
for target organ systemic toxicity, >=0.1% for known or presumed human
carcinogens, etc. (See Ref. 10, chapter 1.5. The cut-off levels for
each hazard class are provided in chapters 3.1-3.10 and chapter 4.1 of
Ref. 10.) When a chemical is present below these cut-off levels, the
GHS does not require that the chemical appear on labeling or other
information sources. The GHS represents international consensus on
appropriate de minimis concentrations below which governments do not
find information useful for hazard communication on chemicals in
international (or domestic) commerce. The focus of GHS is relevant to
that of TSCA section 12(b), which is primarily intended to alert and
inform foreign governments, in a general manner, of hazards that may be
associated with a chemical substance or mixture. As a result, EPA
believes it is logical to refer to GHS as a guide to
[[Page 6738]]
implementation of TSCA section 12(b). EPA believes the inclusion of de
minimis concentration thresholds in GHS is indicative of foreign
governments' likely preference not to be notified by the United States
about its export of chemicals present in low concentrations.
In order to implement an exemption from export notification
requirements for chemicals exported in de minimis concentrations EPA is
proposing de minimis concentration levels below which notification
would not be required for the export of any chemical for which export
notification under TSCA section 12(b) is otherwise required.
Specifically, EPA is proposing that export notification would not be
required for such chemicals if the chemical is being exported at a
concentration of less than 1% (by weight or volume), with two
exceptions. The first exception would be made for chemicals treated for
export notification purposes as carcinogens or potential carcinogens.
These chemicals would be identified in the regulation based on the
three sources referred to in OSHA's regulations related to hazard
communication (29 CFR 1910.1200(d)(4)), i.e.,:
1. Listed as a ``known to be human carcinogen'' or ``reasonably
anticipated to be human carcinogen'' in the Report on Carcinogens
issued by the U.S. Department of Health and Human Services National
Toxicology Program (NTP) (Ref. 1),
2. Classified as a Group 1, Group 2A, or Group 2B carcinogen by the
World Health Organization International Agency for Research on Cancer
(IARC) in the list of IARC Monographs on the Evaluation of Carcinogenic
Risks to Humans and their Supplements (Ref. 2), or
3. Characterized as a carcinogen or potential carcinogen in OSHA's
regulations related to toxic and hazardous substances (29 CFR part
1910, subpart Z).
For paragraphs 1-3 of this unit, a de minimis concentration level of
less than 0.1% (by weight or volume) would apply.
The NTP Report on Carcinogens is mandated by section 301(b)(4) of
the Public Health Service Act, as amended (42 U.S.C. 201 et seq.),
which stipulates that the Secretary of the Department of Health and
Human Services shall publish an annual report which contains a list of
all substances:
Which either are known to be carcinogens in humans or may
reasonably be anticipated to be human carcinogens.
To which a significant number of persons residing in the
United States are exposed.
In 1993, Public Law 95-622 was amended to change the frequency of
publication of the NTP Report on Carcinogens from an annual to a
biennial report.
The IARC Monographs on the Evaluation of Carcinogenic Risks to
Humans are independent assessments prepared by international working
groups of experts of the evidence on the carcinogenicity of a wide
range of agents, mixtures, and exposures. The evaluations of IARC
Working Groups are scientific, qualitative judgments on the evidence
for or against carcinogenicity provided by the available data. The
Monographs are used by national and international authorities to make
risk assessments, formulate decisions concerning preventive measures,
provide effective cancer control programs, and decide among alternative
options for public health decisions.
Copies of the NTP and IARC lists referenced in this proposed rule
have been placed in the public version of the official record for this
rulemaking. In the final rule, EPA intends to seek approval from the
Director of the Office of the Federal Register for the incorporation by
reference of the NTP and IARC lists used in the final rule in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
The third source of carcinogens or potential carcinogens which is
referred to in OSHA's regulations related to hazard communication (29
CFR 1910.1200(d)(4)) is the group of carcinogens or potential
carcinogens in OSHA's toxic and hazardous substances regulations (29
CFR part 1910, subpart Z). In lieu of referencing OSHA's regulations
directly in the regulatory text of this proposed rule, this proposed
rule republishes the two chemicals characterized by OSHA as carcinogens
or potential carcinogens that are not already included on either the
NTP or IARC lists referenced in this proposed rule. The rest of the
chemicals characterized by OSHA as carcinogens or potential carcinogens
are included on either or both the NTP and/or IARC lists.
EPA would update the lists of chemicals identified in its export
notification regulation as carcinogens or potential carcinogens, as
appropriate, in order to reflect changes made to the sources referred
to in OSHA's hazard communication regulations at 29 CFR
1910.1200(d)(4).
Concentration threshold levels like those used in the GHS context
are also generally accepted or recognized in other United States
Federal regulatory contexts. OSHA has established 1.0% and 0.1%
concentration thresholds as a basis for requiring the development of
Material Safety Data Sheets (MSDSs) and workplace labeling under the
OSHA's Hazard Communication (HAZCOM) Standard (29 CFR 1910.1200 and
Ref. 11). The Emergency Planning and Community Right-to-Know Act,
section 313 (Toxic Release Inventory (TRI)) regulations use the OSHA
HAZCOM Standard for purposes of establishing a chemical's de minimis
concentration as either 1.0% or 0.1% for chemical substances when
present in a mixture (40 CFR 372.38(a)). EPA's TSCA New Chemicals
Program also uses concentration limits of 1.0% and 0.1% in TSCA section
5(e) consent orders as thresholds for hazard communication and personal
protective equipment requirements (Ref. 12).
EPA believes that in the context of TSCA section 12(b) export
notification, foreign governments would have little interest in notices
regarding exports of chemicals present in de minimis concentrations,
and that notices for such exports may divert attention from notices for
exports of chemicals in higher concentrations that potentially may
warrant more serious consideration. Thus, EPA believes that de minimis
concentration thresholds are justified in the context of its TSCA
section 12(b) regulations and is proposing that the export of chemicals
present at a concentration below the specified de minimis concentration
levels be exempt from notification requirements.
As EPA has noted in the past, some chemicals retain their toxic
properties at levels less than the general thresholds proposed, so the
de minimis concentration thresholds proposed in this TSCA section 12(b)
context are not an indication that EPA has determined that chemicals
are generally not toxic at lesser concentrations. The de minimis
concentration exemption in this proposal is only a reflection of the
circumstances under which EPA believes foreign governments want to
receive information regarding chemicals imported into their countries.
In this proposed rule, the second exception to the proposed
generally applicable de minimis concentration levels would be made for
PCBs, which, when exported in a concentration of greater than 50 ppm,
would require the submission of an export notification. EPA believes it
is appropriate to include a different de minimis concentration level
for PCBs in its TSCA section 12(b) regulations (i.e., levels less than
or equal to 50 ppm versus the proposed general
[[Page 6739]]
1%/0.1% for carcinogens levels) after considering the coverage of PCBs
under certain international treaties and/or guidance materials
developed thereunder, including the Stockholm Convention and the Basel
Convention on the Control of Transboundary Movements of Hazardous
Wastes and their Disposal (Basel Convention) (Ref. 13). Note that the
manufacture and distribution in commerce of PCBs for use within the
United States or for export from the United States are generally
prohibited, with certain exceptions (see, for example, 40 CFR 761.20(b)
and (c)).
The Stockholm Convention, which entered into force on May 17, 2004,
and for which there were 113 Parties and 151 Signatories as of November
2005 (the United States is a Signatory but not yet a Party), includes,
among other things, provisions that require Parties to reduce and/or
eliminate the production and use of listed intentionally produced
chemicals or pesticides. Annex A of the Stockholm Convention lists
chemicals subject to elimination, including PCBs which are listed with
a specific exemption for ``articles in use in accordance with the
provisions of Part II of this Annex.'' Part II of Annex A of the
Stockholm Convention states, in part:
``Each Party shall:
(a) With regard to the elimination of the use of polychlorinated
biphenyls in equipment (e.g., transformers, capacitors or other
receptacles containing liquid stocks) by 2025, subject to review by the
Conference of the Parties, take action in accordance with the following
priorities . . .
(iii) Endeavour to identify and remove from use equipment
containing greater than 0.005 percent [50 ppm] polychlorinated
biphenyls and volumes greater than 0.05 litres
. . .
(d) Except for maintenance and servicing operations, not allow
recovery for the purpose of reuse in other equipment of liquids with
polychlorinated biphenyls content above 0.005 per cent;
(e) Make determined efforts designed to lead to environmentally
sound waste management of liquids containing polychlorinated biphenyls
and equipment contaminated with polychlorinated biphenyls having a
polychlorinated biphenyls content above 0.005 per cent, in accordance
with paragraph 1 of Article 6, as soon as possible but no later than
2028, subject to review by the Conference of the Parties;
(f) In lieu of note (ii) in Part I of this Annex, endeavour to
identify other articles containing more than 0.005 per cent
polychlorinated biphenyls (e.g., cable-sheaths, cured caulk and painted
objects) and manage them in accordance with paragraph 1 of Article 6;''
Annex A of the Stockholm Convention thus focuses attention on PCBs
in equipment or articles where the PCBs are at a concentration of more
than 50 ppm.
In addition, the Basel Convention, which entered into force on May
5, 1992, and for which there were 166 governments that were Parties as
of November 2005 (the United States is a Signatory but not yet a
Party), stipulates that any trans-boundary movement of wastes (export,
import, or transit) is permitted only when the movement itself and the
disposal of the concerned hazardous or other wastes are environmentally
sound. The Stockholm Convention directs close cooperation with the
Basel Convention to define a ``low POPs content'' for purposes of safe
disposal of wastes contaminated with POPs. Under the Basel Convention,
``General Technical Guidelines for the Environmentally Sound Management
of Wastes Consisting of, Containing or Contaminated with Persistent
Organic Pollutants'' (Basel POPs Guidelines) have been developed that
provisionally identify the level of 50 milligrams/kilograms (mg/kg) (50
ppm) as ``low POPs content'' for PCBs (Ref. 14).
Because the 50 ppm level is used in the Stockholm Convention as a
cut-off level for purposes of obligations associated with PCB-
containing equipment and has been further supported by the Basel POPs
Guidelines as a low level not warranting the attention and control
required for higher PCB levels, EPA believes it reasonable to propose
using it as the basis of a de minimis concentration level for PCBs
under TSCA section 12(b). Thus, at this time, EPA believes importing
governments would not desire export notices from the United States for
PCBs at levels of 50 ppm or less. EPA specifically seeks comment on
whether 50 ppm is a reasonable level for the purposes of TSCA section
12(b), and if not, what other, if any, level may be appropriate and why
(see Unit VI.).
EPA believes that the most practical means of maintaining the
quality of notification, of improving the scrutiny importing countries
give to notices, and of reducing burden on both exporters and EPA, is
to amend the TSCA section 12(b) regulations under 40 CFR part 707 to
reduce the frequency of certain export notifications submitted by
exporters to EPA as well as EPA notices sent to foreign governments.
EPA's responsibility is both to alert and to make information and data
available to the importing government. EPA believes that although the
frequency of EPA's notices to foreign governments may be reduced by
this rule, if finalized as proposed, the quality of the information
provided to them would not be substantially affected.
IV. Additional Proposed Amendments and Clarifications
In addition to the proposed amendments to the TSCA section 12(b)
regulations regarding the scope of exporters' and EPA's
responsibilities, the Agency is proposing minor amendments to update
the EPA addresses to which export notifications must be sent (40 CFR
707.65(c)), to indicate that a single export notification may refer to
more than one section of TSCA where the exported chemical is the
subject of multiple TSCA actions(40 CFR 707.67), and to correct an
error in 40 CFR 799.19, which currently omits mentioning multi-chemical
test rules as being among those final TSCA section 4 actions that
trigger export notification.
EPA is also clarifying exporters' and EPA's obligations where a
TSCA section 12(b)-triggering action is taken with respect to a
chemical previously or currently subject to export notification due to
the existence of a previous triggering action. EPA's intention is that
exporters notify EPA with respect to each TSCA section 12(b)-triggering
action to which the chemical becomes subject (as long as the exporter
in fact still exports or intends to export the chemical to that
country) even if they have previously notified EPA about the export of
that chemical to that country as a result of an earlier TSCA section
12(b)-triggering action. Note that an export notification may indicate
more than one triggering action, i.e., separate export notifications
need not be submitted where the need for export notification as a
result of more than one triggering action at the same time exists with
respect to a given chemical. Similarly, EPA would notify a foreign
government with respect to each TSCA section 12(b)-triggering action to
which the chemical becomes subject (as long as the Agency continues to
receive an export notification from any exporter for the export of the
chemical to that country) even if it has previously notified that
government about the export of the chemical as a result of an earlier
TSCA section 12(b)-triggering action. In this proposed rule, EPA is
amending 40 CFR 707.65 and 707.70 in order to make these obligations
clear.
[[Page 6740]]
V. Economic Impact
EPA has evaluated the potential costs of these proposed amendments.
The Agency anticipates that these proposed amendments would reduce the
number of export notifications sent to EPA by exporters of chemicals
that are the subject of actions under TSCA section 5(e), 5(a)(2), or
5(b), and that they would also eliminate the submission of export
notifications from exporters of chemicals otherwise subject to TSCA
section 12(b) where they are present at a concentration below the
relevant de minimis concentration threshold. The amendments would also
potentially reduce the number of export notices sent by EPA to foreign
governments. These reductions would save both exporter and EPA
resources.
For the period 1996-2004, EPA received an average of approximately
8,600 export notifications from exporters annually. On average, each
year nearly 60% of those export notifications were for chemicals
subject to final TSCA section 4 actions, 25% for chemicals that were
the subject of actions under TSCA section 5, and the remainder were
primarily for chemicals that were the subject of actions under TSCA
section 6 and a very few for chemicals subject to actions under TSCA
section 7. At this time, EPA is unable to predict with certainty the
reduction in export notifications received by EPA from exporters due to
the de minimis concentration exemption of this proposed rule, but based
on personal communication with the American Chemistry Council (ACC)
(Ref. 15), EPA is estimating a 5% across-the-board reduction in TSCA
section 12(b) notification burden to exporters due to the de minimis
concentration exemption. Based on historical reporting, EPA is able to
estimate, after the first year, a 50% reduction in export notifications
triggered by TSCA section 5(e), 5(a)(2), or 5(b) actions as a result of
the one-time-only provision, if these amendments are finalized as
proposed. Thus, EPA expects to receive roughly 8,170 export
notifications in the first year, and 7,125 in all subsequent years.
These reductions are expected to save the regulated community over
$12,000 in the first year of the proposed rule (3%), and over $41,000
in subsequent years (12%). Over 20 years, if finalized as proposed,
these proposed amendments would save the regulated community
approximately $440,000 at a 7% discount rate, and over $600,000 at a 3%
discount rate. See the Economic Analysis of the Proposed Change to TSCA
Section 12(b) Export Notification Requirements (Ref. 16) for details on
all cost and burden calculations.
The costs to EPA would also likely be reduced based on these
proposed amendments, as EPA incurs costs for processing export
notifications received, and for sending export notices to foreign
governments. While EPA has been sending roughly 1,600 notices to
foreign governments annually, that number is expected to drop as a
result of these proposed amendments, if finalized as proposed, to an
estimated 1,520 notice during the first year in which the rule is
effective, and an estimated 980 notices sent in all subsequent years.
These reductions are expected to save the Federal Government over
$7,500 during the first year in which the rule is effective (4% of
current costs), and over $43,000 in subsequent years (24% of current
costs). Over 20 years, these proposed amendments, if finalized as
proposed, would save the Federal Government approximately $450,000 at a
7% discount rate, and roughly $630,000 at a 3% discount rate.
VI. Request for Comment
The following is a list of issues on which the Agency is
specifically requesting public comment. EPA encourages all interested
persons to submit comments on these issues, and to identify any other
relevant issues as well. This input will assist the Agency in
developing a rule that successfully addresses information needs while
minimizing potential reporting burdens associated with the rule. EPA
requests that commenters making specific recommendations include
supporting documentation where appropriate.
1. Based on certain international efforts, specifically GHS and the
Stockholm Convention (and the Basel POPs Guidelines), EPA believes
foreign governments would have little interest in TSCA section 12(b)
notices regarding exports of chemicals present in low concentrations
(i.e., 1%, 0.1%, or, for PCBs, 50 ppm or less). EPA specifically seeks
comment on whether the proposed thresholds are set at a reasonable
level for the purposes of TSCA section 12(b), and if not, what other,
if any, level(s) may be appropriate and why.
2. This proposal makes the point that GHS represents international
consensus on appropriate de minimis concentrations below which foreign
governments do not find information useful for hazard communication on
chemicals in international commerce. As with TSCA section 12(b), one of
the primary purposes of the GHS labeling scheme is to communicate
information on chemicals to foreign governments. Accordingly, EPA
believes it is appropriate to look to GHS for guidance on establishing
a de minimis concentration exemption under TSCA section 12(b). EPA is
specifically seeking comment on the appropriateness of using GHS.
3. The proposal uses the Stockholm Convention as a basis for
selecting a 50 ppm threshold for PCBs. Is this appropriate?
4. EPA estimates that the proposed de minimis concentration
exemption would reduce the burden of TSCA section 12(b) reporting by
5%. However, since EPA does not currently require exporters to consider
the concentration of chemicals they are exporting, the potential burden
reduction is difficult to estimate. EPA is seeking information that
might further inform the Agency's burden estimate.
VII. References
The official record for this proposed rule has been established
under docket ID number EPA-HQ-OPPT-2005-0058, and the public version of
the official record is available for inspection as specified under
ADDRESSES. These references have been placed in the public docket.
1. Report on Carcinogens, Eleventh Edition; United States
Department of Health and Human Services, Public Health Service,
National Toxicology Program. Available online at http://ntp.niehs.nih.gov/index.cfm?objectid=32BA9724-F1F6-975E-7FCE50709CB4C932 7FCE50709CB4C932.
2. International Agency for Research on Cancer Monographs on the
Evaluation of Carcinogenic Risks to Humans and their Supplements.
Available online at http://www-cie.iarc.fr/monoeval/allmonos.html.
3. EPA. 1980. Chemical Imports and Exports; Notification of Export.
Final Rule. Federal Register (45 FR 82844, December 16, 1980).
Available on-line at http://www.heinonline.org/HOL/Index?index=fedreg/fedreg&collection=fedreg.
4. EPA. 1993. Export Notification Requirement; Change to Reporting
Requirements. Final Rule. Federal Register (58 FR 40238, July 27,
1993). Available on-line at http://www.heinonline.org/HOL/Index?index=fedreg/fedreg&collection=fedreg.
5. Rotterdam Convention on the Prior Informed Consent Procedure for
Certain Hazardous Chemicals and Pesticides in International Trade.
September, 1998 (amended September 2004). Available on-line at http://www.pic.int/en/viewpage.asp?id_cat=0. Annex III: Chemicals Subject to
the Prior Informed
[[Page 6741]]
Consent Procedure. Available on-line at http://www.pic.int/en/ViewPage.asp?id=104#III%20Annex.
6. Harmonized System Convention, World Customs Organization (WCO).
Available on-line at http://www.wcoomd.org/ie/En/Topics_Issues/topics_issues.html. June 14, 1983. The Harmonized Commodity
Description and Coding System, generally referred to as ``Harmonized
System'' or simply ``HS,'' is a multi-purpose international product
nomenclature developed by the WCO.
7. Stockholm Convention on Persistent Organic Pollutants (POPs).
May 22, 2001. Available on-line at http://www.pops.int.
8. United Nations Economic Commission for Europe Convention on Long
Range Transboundary Air Pollution (LRTAP) Protocol on Persistent
Organic Pollutants (POPs), June 24, 1998. Available on-line at http://www.unece.org/env/lrtap/pops_h1.htm.
9. United Nations Conference on Environment and Development (Earth
Summit) Agenda 21; Chapter 19: Environmentally Sound Management of
Toxic Chemicals, Including Prevention of Illegal International Traffic
in Toxic and Dangerous Products. Rio de Janeiro, June 1992. Available
on-line at http://www.un.org/esa/sustdev/documents/agenda21/english/agenda21chapter19.htm.
10. GHS. Available on-line at http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html. United Nations, 2003. GHS Chapter 1.5:
Hazard Communication: Safety Data Sheets Table 1.5.1: Cut-off values/
concentration limits for each health and environmental hazard class.
See http://www.unece.org/trans/danger/publi/ghs/ghs_rev01/English/01e_part1.pdf.GHS Chapter 1.3: Classification of Hazardous Substances
and Mixtures Subparagraph 1.3.3.2: Use of cut-off values/concentration
limits. See http://www.unece.org/trans/danger/publi/ghs/ghs_rev00/English/GHS-PART-3e.pdf.
11. OSHA. Hazard Communication, Final Rule. Federal Register (48 FR
53280-53348, November 25, 1983). For discussion of 1% and 0.1%
concentration thresholds, see pages 53290-53293.
12. New Chemicals Program Boilerplate TSCA Section 5(e) Consent
Orders. Available on-line at http://www.epa.gov/opptintr/newchems/boilerpl.htm.
13. Basel Convention on the Control of Transboundary Movements of
Hazardous Wastes and their Disposal Adopted by the Conference of the
Plenipotentiaries March 22 1989. Entry into force May 1992.
14. Basel Convention General Technical Guidelines for
Environmentally Sound Management of wastes consisting of, containing or
contaminated with Persistent Organic Pollutants (POPs). April 2005. See
http://www.basel.int/techmatters/techguid/frsetmain.php.
15. Personal Communication. James Miller, EPA Economist, and
members of the American Chemistry Council's TSCA Action Group. November
15, 2005.
16. Economic and Policy Analysis Branch, Office of Pollution
Prevention and Toxics, EPA. November 2005. Economic Analysis of the
Proposed Change to TSCA Section 12(b) Export Notification Requirements.
VIII. Statutory and Executive Order Reviews
A. Executive Order 12866
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that this proposed rule is not a
``significant regulatory action'' under section 3(f) of the Executive
Order.
In addition, EPA has prepared an economic assessment of the
potential costs and benefits associated with this proposed action,
which is contained in a document entitled Economic Analysis of the
Proposed Change to TSCA Section 12(b) Export Notification Requirements
(Ref. 16). This document is available in the docket, and is briefly
summarized in Unit V.
B. Paperwork Reduction Act
This action does not impose any new information collection burden
that would require additional approval by OMB under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq. This rule is expected to
reduce the existing burden that is approved under OMB Control No. 2070-
0030 (EPA ICR No. 0795), which covers the information collection
activities contained in the existing regulations at 40 CFR part 707,
related to export notification under TSCA section 12(b).
The annual respondent burden for the collection of information
currently approved by OMB is estimated to be about 1 hour per response.
A copy of the OMB approved Information Collection Request (ICR) has
been placed in the docket for this rulemaking, and the Agency's
estimated burden reduction is presented in the Economic Analysis (Ref.
16) that has been prepared for this rule.
Under the PRA, ``burden'' means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information that is subject to approval
under the PRA, unless it displays a currently valid OMB control number.
The OMB control numbers for EPA's regulations in title 40 of the CFR,
after appearing in the Federal Register when approved, are listed in 40
CFR part 9, are displayed either by publication in the Federal Register
or by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
in certain EPA regulations is consolidated in 40 CFR part 9.
Submit any comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden, including the use of automated
collection techniques, along with your comments on the proposed rule.
The Agency will consider any comments related to the information
collection requirements contained in this proposal as it develops a
final rule. Any changes to the burden estimate for the ICR will be
effectuated with the final rule.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., due to the burden-reducing nature of this rule,
the Agency hereby certifies that this proposed rule will not have a
significant adverse economic impact on a substantial number of small
entities. The factual basis for the Agency's determination is presented
in the small entity impact analysis prepared as part of the Economic
Analysis for this proposed rule (Ref. 16), which is summarized in Unit
V., and a copy of which is available in the docket for this rulemaking.
The
[[Page 6742]]
following is a brief summary of the factual basis for this
certification.
For purposes of assessing the impacts of this proposed rule on
small entities, small entity is defined as:
1. A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201 based on the
applicable NAICS code for the business sector impacted.
2. A small governmental jurisdiction that is a government of a
city, county, town, school district or special district with a
population of less than 50,000.
3. A small organization that is any not-for-profit enterprise which
is independently owned and operated and is not dominant in its field.
Available information indicates that small governmental jurisdictions
and small not-for-profit organizations would not generally engage in
the activities regulated. As such, the Agency assessed the impacts on
small exporters of chemical substances or mixtures within NAICS codes
325 (chemical manufactures and processors) and 324110 (petroleum
refineries).
As discussed in Unit V., this proposed rule, if finalized as
proposed, will amend an existing requirement and result in a reduction
of burden and costs for exporters, regardless of the size of the firm.
As such, these amendments will not have a significant adverse economic
impact on a substantial number of small entities.
D. Unfunded Mandates Reform Act
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995
(UMRA), Public Law 104-4, EPA has determined that this proposed rule,
which would result in a burden reduction upon being finalized, does not
contain a Federal mandate that may result in expenditures of $100
million or more for State, local, and tribal governments, in the
aggregate, or the private sector in any 1 year. It is estimated that
the total cost reduction of the rule, which is summarized in Unit V.
and presented in the Economic Analysis (Ref. 16), over 20 years, would
be $440,000 to $600,000 to the regulated community and $450,000 to
$630,000 to the Federal Government. In addition, based on EPA's
experience with the TSCA 12(b) reporting, State, local, and tribal
governments have not been affected by this reporting requirement, and
EPA does not have any reason to believe that any State, local, or
tribal government will be affected by these proposed amendments. As
such, EPA has determined that this regulatory action does not impose
any enforceable duty, contain any unfunded mandate, or otherwise have
any affect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205.
E. Executive Order 13132
Pursuant to Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999), EPA has determined that this proposed rule
does not have ``federalism implications,'' because it will not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in the Order. As indicated previously, EPA does not have any
reason to believe that any State or local government will be affected
by these proposed amendments. Thus, Executive Order 13132 does not
apply to this proposed rule.
F. Executive Order 13175
As required by Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000), EPA has determined that this proposed rule does not have tribal
implications because it will not have any affect on tribal governments,
on the relationship between the Federal Government and the Indian
tribes, or on the distribution of power and responsibilities between
the Federal Government and Indian tribes, as specified in the Order. As
indicated previously, EPA does not have any reason to believe that any
tribal governments will be affected by these proposed amendments. Thus,
Executive Order 13175 does not apply to this proposed rule.
G. Executive Order 13045
This proposed rule does not require special consideration pursuant
to the terms of Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997), because this proposed rule is not designated as an
``economically significant'' regulatory action as defined by Executive
Order 12866, nor does it establish an environmental standard, or
otherwise have a disproportionate effect on children.
H. Executive Order 13211
This proposed rule is not subject to Executive Order 13211,
entitled Actions concerning Regulations that Significantly Affect
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) because
it is not designated as an ``economically significant'' regulatory
action as defined by Executive Order 12866, nor is it likely to have
any significant adverse effect on the supply, distribution, or use of
energy.
I. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, 12(d) (15 U.S.C. 272 note),
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures and business practices) that are developed or adopted by
voluntary consensus standards bodies. The NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
This proposed rule does not impose any technical standards that
would require EPA to consider any voluntary consensus standards.
J. Executive Order 12898
This proposed rule does not have an adverse impact on the
environmental and health conditions in low-income and minority
communities. Therefore, under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994), the Agency does
not need to consider environmental justice-related issues.
List of Subjects in 40 CFR Parts 707 and 799
Environmental protection, Chemicals, Exports, Hazardous substances,
Imports, Reporting and recordkeeping requirements.
Dated: January 31, 2006.
Susan B. Hazen,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 707--[AMENDED]
1. The authority citation for part 707 continues to read as
follows:
Authority: 15 U.S.C 2611(b) and 2612.
2. By redesignating paragraphs (c) through (e) of Sec. 707.60 as
paragraphs (d) through (f) of Sec. 707.60.
3. By adding a new paragraph (c) to Sec. 707.60 and revising newly
[[Page 6743]]
redesignated paragraph (d) of Sec. 707.60 to read as follows:
Sec. 707.60 Applicability and compliance.
* * * * *
(c) No notice of export is required for the export of a chemical
substance or mixture for which export notification is otherwise
required, where such chemical substance or mixture is present in a
concentration of less than 1% (by weight or volume), except that:
(1) No notice of export is required for the export of the following
chemical substances or mixtures where such chemical substance or
mixture is present in a concentration of less than 0.1% (by weight or
volume) (The listed chemicals and mixtures are treated by EPA in
paragraph (c)(1) of this section as carcinogens or potential
carcinogens for the limited purpose of application of the 0.1%
concentration export notification threshold.):
(i) A chemical substance or mixture listed as a ``known to be human
carcinogen'' or ``reasonably anticipated to be human carcinogen'' in
the Report on Carcinogens, Eleventh Edition issued by the U.S.
Department of Health and Human Services National Toxicology Program,
(ii) A chemical substance or mixture classified as a Group 1, Group
2A, or Group 2B carcinogen by the World Health Organization
International Agency for Research on Cancer (IARC) in the list of IARC
Monographs on the Evaluation of Carcinogenic Risks to Humans and their
Supplements, or
(iii) Alpha-naphthylamine (Chemical Abstract Service Registry
Number (CAS No.) 134-32-7) or 4-nitrobiphenyl (CAS No. 92-93-3).
(2) No notice of export is required for the export of
polychlorinated biphenyl chemicals (PCBs) (see definition in 40 CFR
761.3), where such chemical substances are present in a concentration
of less than or equal to 50 ppm (by weight or volume).
(d) Any person who exports or intends to export PCBs or PCB
articles (see definition in 40 CFR 761.3), for any purpose other than
disposal, shall notify EPA of such intent or exportation under TSCA
section 12(b), except as specified in Sec. 707.60(c)(2).
* * * * *
4. By revising pragraph (a) introductory text, (a)(2), and (c) of
Sec. 707.65 to read as follows:
Sec. 707.65 Submission to agency.
(a) For each action under TSCA triggering export notification,
exporters must notify EPA of their export or intended export of each
subject chemical substance or mixture for which export notice is
required under Sec. 707.60 in accordance with the following:
* * * * *
(2) (i) The notice must be for the first export or intended export
by an exporter to a particular country in a calendar year when the
chemical substance or mixture is the subject of an order issued, an
action that is pending, or relief that has been granted under TSCA
section 5(f), a rule that has been proposed or promulgated under TSCA
section 6, or an action that is pending or relief that has been granted
under TSCA section 7.
(ii) The notice must be for only the first export or intended
export by an exporter to a particular country when the chemical
substance or mixture is the subject of an order issued, an action that
is pending, or relief that has been granted under TSCA section 5(e), a
rule that has been proposed or promulgated under TSCA section 5(a)(2),
or when the submission of data is required under TSCA section 4 or
5(b).
* * * * *
(c) Notices shall be marked ``TSCA Section 12(b) Notice'' and sent
to EPA by mail or delivered by hand or courier. Send notices by mail
to: Document Control Office (7407M), Office of Pollution Prevention and
Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW., Washington, DC 20460-0001 (Attention: TSCA Section 12(b) Notice).
Hand delivery of TSCA section 12(b) notices should be made to: OPPT
Document Control Office (DCO), EPA East Bldg., Rm. 6428, Environmental
Protection Agency, 1201 Constitution Ave., NW., Washington, DC
(Attention: TSCA Section 12(b) Notice). The DCO is open from 8 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The telephone
number for the DCO is (202) 564-8930. Such deliveries are only accepted
during the DCO's normal hours of operation.
5. By adding an ``and/'' in front of the ``or'' in the first
sentence of paragraph (a) and paragraph (e) of Sec. 707.67.
6. By revising paragraph (a) of Sec. 707.70 to read as follows:
Sec. 707.70 EPA notice to foreign governments.
(a)(1) Notice by EPA to the importing country shall be sent no
later than 5 working days after receipt by the TSCA Document Processing
Center of the first annual notification from any exporter for each
chemical substance or mixture that is the subject of an order issued,
an action that is pending, or relief that has been granted under TSCA
section 5(f), a rule that has been proposed or promulgated under TSCA
section 6, or an action that is pending or relief that has been granted
under TSCA section 7.
(2) Notice by EPA to the importing country shall be sent no later
than 5 working days after receipt by the TSCA Document Processing
Center of the first notification from any exporter for each chemical
substance or mixture that is the subject of an order issued, an action
that is pending, or relief that has been granted under TSCA section
5(e), a rule that has been proposed or promulgated under TSCA section
5(a)(2), or for which the submission of data is required under TSCA
section 4 or 5(b).
* * * * *
PART 799--[AMENDED]
7. The authority citation for part 799 continues to read as
follows:
Authority: 15 U.S.C 2603, 2611, 2625.
8. By revising Sec. 799.19 to read as follows:
Sec. 799.19 Chemical imports and exports.
Persons who export or who intend to export chemical substances or
mixtures listed in subpart B, subpart C, or subpart D of this part are
subject to the requirements of part 707 of this title.
[FR Doc. E6-1797 Filed 2-8-06; 8:45am]
BILLING CODE 6560-50-S